Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human...

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)

Apr 19, 2021 · The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients.

The ICH guideline for good clinical practice (GCP) establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants.

ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients.

9 The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual 10 acceptance of clinical trial data for ICH member countries and regions by applicable regulatory 11 authorities. 12 This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for 13 Clinical Studies.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

ICH Good Clinical Practice (GCP) is the widely used international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of human research participants are protected and that research data are reliable.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E6(R3) Guideline for Good Clinical Practice.”